1. Field of the Invention
The present invention relates generally to fluid delivery devices. More particularly, the invention concerns an improved apparatus for infusing medicinal agents into an ambulatory patient at specific visual rates over extended periods of time, which apparatus includes both flow indicators means and a novel vial assembly fill means for filling the reservoir of the device.
2. Discussion of the Invention
Many medicinal agents require an intravenous route for administration thus bypassing the digestive system and precluding degradation by the catalytic enzymes in the digestive tract and the liver. The use of more potent medications at elevated concentrations has also increased the need for accuracy in controlling the delivery df such drugs. The delivery device, while not an active pharmacologic agent, may enhance the activity of the drug by mediating its therapeutic effectiveness. Certain classes of new pharmacologic agents possess a very narrow range of therapeutic effectiveness, for instance, too small a dose results in no effect, while too great a dose results in toxic reaction.
In the past, prolonged infusion of fluids has generally been accomplished using gravity flow methods, which typically involve the use of intravenous administration sets and the familiar bottle suspended above the patient. Such methods are cumbersome, imprecise and require bed confinement of the patient. Periodic monitoring of the apparatus by the nurse or doctor is required to detect malfunctions of the infusion apparatus.
Devices from which liquid is expelled from a relatively thick-walled bladder by internal stresses within the distended bladder are well-known in the prior art. Such bladder, or "balloon" type, devices are described in U.S. Pat. No. 3,469,578, issued to Bierman and in U.S. Pat. No. 4,318,400, issued to Perry. The devices of the aforementioned patents also disclose the use of fluid flow restrictors external of the bladder for regulating the rate of fluid flow from the bladder.
The prior art bladder type infusion devices are not without drawbacks. Generally, because of the very nature of the bladder or "balloon" configuration, the devices are unwieldy and are difficult and expensive to manufacture and use. Further, the devices are somewhat unreliable and their fluid discharge rates are frequently imprecise.
The apparatus of the present invention overcomes many of the drawbacks of the prior art by eliminating the bladder and making use of recently developed elastomeric films and similar materials, which, in cooperation with a base define a fluid chamber that contains the fluid which is to be dispensed. The elastomeric film membrane controllably forces fluid within the chamber into fluid flow channels provided in the base.
The elastomeric film materials used in the apparatus of the present invention, as well as various alternate constructions of the apparatus, are described in detail in U.S. Pat. No. 5,205,820 issued to the present inventor. Therefore, U.S. Pat. No. 5,205,820 is hereby incorporated by reference in its entirety as though fully set forth herein. Co-pending U.S. Ser. No. 08/046,438 filed by the present inventor on May 18, 1993 also describes various alternate constructions and modified physical embodiments of the invention. This co-pending application is also hereby incorporated by reference in its entirety as though fully set forth herein. Because the present application discloses a novel improvement to the apparatus described in co-pending U.S. Ser. No. 08/432,221 filed May 1, 1995, this co-pending application is also hereby incorporated by reference in its entirety as though fully set forth herein.
The apparatus of the present invention can be used with minimal professional assistance in an alternate health care environment, such as the home. By way of example, devices of the invention can be comfortably and conveniently removably affixed to the patient's body and can be used for the continuous infusion of antibiotics, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents. Similarly, the devices can be used for I-V chemotherapy and can accurately deliver fluids to the patient in precisely the correct quantities and at extended microfusion rates over time.
The embodiments of the invention described in Ser. No. 08/432,221, which application is incorporated herein by reference, comprises a fluid delivery apparatus having a fluid reservoir, fluid flow control assembly, and an indicator assembly for indicating fluid flow through the apparatus. However, unlike the apparatus of the present invention, which includes a unique vial fill assembly for filling the reservoir, the reservoir of the apparatus described in Ser. No. 08/432,221 is filled from an external fluid source which is connected to a conventional luer connector provided on the base of the device. As will be better understood from the description which follows, the novel vial fill assembly of the present invention significantly expands the capability of the apparatus, including enabling the reservoir of the device to be filled at time of usability to controllably fill the reservoir of the device with a wide variety of medicinal fluids that can be conveniently stored within the prefilled vial component of the vial assembly.